COFEPRIS’s New Molecules Registry Updated

Last week, COFEPRIS announced the optimization of its processes, leading to the approval of 162 new treatments by the New Molecules Committee (CMN). “We have finished with the historical lag of the CMN. With 158 molecules with favorable resolutions and an additional 17 to attend COVID-19 and oncology, we say goodbye to the delay and contribute to supply and innovation in our country,” announced Federal Commissioner of COFEPRIS, Alejandro Svarch via LinkedIn. The decision was made following best international practices of agencies such as the European Medicines Agency (EMA), added Svarch.

Created in 2008, CMN reviews the safety, quality and efficacy of different health supplies. It is composed of a group of experts who analyze and highlight the clinical value of new therapeutic alternatives. CMN handles new molecule approvals with the goals of improving the health of the population and its quality of life, while reducing hospitalization time, morbidity and mortality. Early access to innovative therapies often translates to positive and measurable health impacts, while slow new approvals leave the health needs of patients unmet.

This recent advancement is very significant, as on 2020 “Mexico (had) disintegrated the Committee of New Molecules, which was key for pharmaceutical innovation in the country. This will slow down innovative product approvals,” explained Arnaud Coelho, Director General of Merck Group México to MBN at the time.

In early 2020, before the pandemic, there were many positive exchanges between pharmaceutical companies and authorities. Back then, “the industry was close to COFEPRIS and the government showed more openness for dialogue,” said Coelho. But the pandemic, caused a significant setback. “We are waiting for things to get back on track once the crisis passes,” he added. Alongside AMIIF and CANIFARMA, the industry was vocal about the need for innovation and access. “Efforts do not have to be based on money; they can be translated to programs, too,” Coelho said.

Rafael Gual, Director General of CANIFARMA told MBN that at least 120 of the recently approved molecules were waiting for approval since June 2020. The delay “heavily affects access to new technologies and, more alarmingly, access to healthcare,” said Gual.

But the slowdown also affected companies. “These delays represented an economic impact for the industry as we have not seen investment returns for these innovations,” said Marco Ruggiero, General Manager of Chiesi Mexico to MBN.

CMN’s recent update requires companies interested in applying for registration with COFEPRIS to fill five modules:

1. Administrative

2. Development

3. Preclinical

4. Clinical

5. Manufacturing

The application process takes an average of nine months, but it can go up to 13 months. However, for an innovative therapeutic option to be effectively available in hospitals and public health institutions, the entire introduction process usually takes about three years. The process, in its entirety after following the stipulated legal times for a new therapeutic option to arrive in Mexico and be available to the entire population in public health institutions, can take up to 4.2 years